Shuxuening injection is a multi-target neuroprotective agent, it is expected to play a neuroprotective role on the basis of intravenous thrombolysis therapy. The primary purpose of this multicenter, randomized, double-blind, placebo-parallel controlled trial is to evaluate the efficacy and safety of Shuxuening injection in the treatment with intravenous thrombolysis in patients with ischemic stroke.
Age 18 or older;
Diagnosed with acute ischemic stroke;
Within 6 hours of onset;
Having received or plan to undergo intravenous thrombolytic therapy;
mRS score greater than 1 point before the onset;
Receiving neuroprotective agents, such as edaravone, edaravone dextrocamphorol, butylphthalein, etc. after the onset;
Bleeding or other pathological brain disorders, such as vascular malformations, tumors, abscesses, or other common non-ischemic brain diseases (such as multiple sclerosis), detected by CT/MRI;
History of clotting disorders, systemic bleeding, thrombocytopenia, or neutropenia;
Parallel
Shuxuening Injection
DrugReceiving 20 ml Shuxuening injection plus 250ml 0.9% sodium chloride injection, intravenous drip once a day, for 10-14 days
Placebo
Other interventionReceiving 20 ml placebo Shuxuening injection plus 250ml 0.9% sodium chloride injection, intravenous drip once a day, for 10-14 days.
The proportion of mRS score 0 to 1 at 90 days after randomization
The Modified Rankin Scale (mRS) score ranges from 0 to 6, with higher scores indicating worse functional outcome.
The proportion of mRS score 0 to 2 at 90 days after randomization
The Modified Rankin Scale (mRS) score ranges from 0 to 6, with higher scores indicating worse functional outcome.
The distribution of mRS scores at 90 days after randomization
The Modified Rankin Scale (mRS) score ranges from 0 to 6, with higher scores indicating worse functional outcome.
NIHSS score improvement ≥4 points from baseline at 14 days after randomization or on discharge
The National Institutes of Health Stroke Scale (NIHSS) score ranges from 0 to 42, with higher scores indicating more severe neurological deficit.
EQ-5D score at 90 days after randomization
The European Quality of Life 5-Dimension 3-Level (EQ-5D-3L) includes five dimensions. The sum score on each of the five dimensions ranges from 5 (all domains have level 1) to 15 (all domains have level 3), with higher scores indicating worse health-related quality of life.
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